VAT-2: Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions in Nursing Homes

NCT ID: NCT05998226

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

Brief Summary

The Virtual Antimicrobial stewardship Team (VAT) study aims to evaluate, in a randomized controlled trial (RCT), the effect of a weekly virtual antimicrobial stewardship (AMS) intervention on the appropriateness of prescribing antibiotics for nursing home (NH) residents with urinary tract infections (UTI), respiratory tract infections (RTI) or skin and soft tissue infections (SSTI) compared to standard care for NH residents in Dutch NHs in the provinces of North-Holland and Flevoland. The secondary aim is to identify barriers and facilitators to implement a stewardship intervention and subsequently develop an implementation guide.

Detailed Description

Rationale: Antimicrobial stewardship interventions have been extensively studied in hospital settings and have proven effective in reducing the number of infections with multidrug resistant micro-organisms and are also cost-effective. Therefore, AMS teams are mandatory in Dutch hospitals.

The effectiveness of an antimicrobial stewardship intervention is variable in previous studies. Also due to the perceived high workload and costs, AMS has hardly been implemented in Dutch NHs. In order to take the next step towards implementation of AMS in NHs, causality between AMS and reduction in inappropriate antibiotic prescriptions should be demonstrated. The investigators want to evaluate the process and value of the VAT approach to facilitate optimal implementation of VAT in other NHs.

Objective: To demonstrate the efficacy of weekly virtual antimicrobial stewardship team meetings in reducing inappropriate antibiotic prescriptions in Dutch NHs.

Study design: randomized, non-blinded, controlled, multicenter trial.

Study population: Clinicians working in NHs in the provinces North Holland and Flevoland.

Intervention: The VAT consists of at least a clinical microbiologist and a clinician from the NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting, based on a standardized protocol according to the current national guidelines.

Main study parameters/endpoints: The primary outcome is the number of inappropriate antibiotic prescriptions, assessed based on an algorithm of the current clinical infection treatment guidelines, antimicrobial susceptibility test results, and clinical characteristics. Each antibiotic prescription is a record and for each record will be assessed whether the antibiotic prescription is appropriate or not. Secondary outcome measures are the incidence rate (IR) of antibiotic prescriptions and facilitators and barriers to VAT implementation.

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard care (control group)

The clinicians from the control arm do not participate in VAT meetings. The antibiotic prescriptions prescribed by clinicians in the control group are extracted from the prescription system after the study period. Two researchers independently extract the data from patient files, including any culture results, and assess the antibiotic use based on the algorithm from the current guidelines that are used in NHs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual Antimicrobial stewardship Team (VAT) (intervention group)

The VAT consists at least of a medical microbiologist and a clinician from the NH. Depending on the NH organization concerned and cooperation agreements, a pharmacist will or will not be involved. They conduct weekly consultations during 9 months to evaluate the antibiotic prescriptions of the clinician based on algorithms from current guidelines in use in the NH. This is an evaluation of standard care .

Group Type: EXPERIMENTAL

Virtual Antimicrobial stewardship Team (VAT)

Intervention Type: OTHER

The VAT consists of at least a clinical microbiologist and a clinician from the NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting, based on a standardized protocol according to the current national infection treatment guidelines.

Interventions

Virtual Antimicrobial stewardship Team (VAT)

The VAT consists of at least a clinical microbiologist and a clinician from the NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting, based on a standardized protocol according to the current national infection treatment guidelines.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Working in nursing homes in the North Holland-Flevoland region and being authorized to prescribe.
• Agreeing to being randomized to intervention or control group.
• Working in a nursing home that has a medication prescription system from which prescriptions can easily be obtained for VAT meetings.
• Working in a nursing home that is connected to a microbiology lab, .that participates in this study and offers VAT meetings.
• Expected to be employed for at least four months from date of randomization.

• All prescriptions for antibiotics with a therapeutic indication regarding urinary tract infections, respiratory tract infections or skin and soft tissue infections for residents of nursing homes, prescribed by clinicians participating in the study, during the study period.

Exclusion Criteria

• Prescriptions for antibiotics with a prophylactic purpose.
• Prescriptions given by clinicians not participating in the study
• Prescriptions prescribed outside the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

OTHER

Sponsor Role: collaborator

Public Health Service of Amsterdam

OTHER_GOV

Sponsor Role: lead

Responsible Party

Maarten Schim van der Loeff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarten MF Schim van der Loeff, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Public Health Service of Amsterdam

Locations

Public Health Service of Amsterdam

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

W23_041 #23.064

Identifier Type: -

Identifier Source: org_study_id